Site Selection for Intracutaneous Saline Delivery

Not Applicable

Completed

• Conditions: Intracutaneous Drug Delivery
• Interventions: Device: Injection to forearm; Device: Injection to thigh; Device: Injection to deltoid

• Registration Number: NCT01767324
• Lead Sponsor: FluGen Inc

Brief Summary

The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.

Detailed Description

Test ability to inject saline into various sites on body.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Able to read and/or understand and sign the Informed Consent Form

Exclusion Criteria

• Medical history of acute or chronic skin disease
• Active skin allergy or acute skin infection, tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
• Hirsute at any prospective injection site
• Diabetes
• High levels of anxiety or depression or history of psychosis
• Abuse of alcohol or use of other drugs of abuse including tobacco
• Pregnant or breastfeeding women
• Any medical condition that may interfere with study protocol adherence including completion of study activities
• Foreseeable inability to complete the study as scheduled.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection to forearm	Injection to forearm	Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Injection to thigh	Injection to thigh	Deliver saline from FLUGEN 101.2 microneedle-based delivery device.
Injection to deltoid	Injection to deltoid	Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.	30 minutes, 24 hours, 1 week	Observe injection sites for change of appearance post-dose including wheal formation or resolution.

Secondary Outcome Measures

Name	Time	Method
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.	3 minutes	Evaluate ability of device to dispense targeted dose volume.

Trial Locations

Locations (1)

Accelovance Inc; 🇺🇸 Melbourne, Florida, United States